Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HCT-44179

Study information

Scientific title

A pilot study to determine the impact of therapeutic Human Immunodeficiency Virus (HIV) vaccination followed by a scheduled interruption of antiretroviral therapy on HIV-specific immune function by a scheduled virologic rebound in patients with prolonged viral suppression

Acronym

Study hypothesis

Human Immunodeficiency Virus (HIV) vaccination results in delayed rebound in plasma Viral Load (pVL) after an interruption of Anti-Retroviral Therapy (ART) compared to an interruption of ART without prior vaccination.

Ethics approval

Ottawa Hospital Research Ethics Board Ottawa approved on the 22nd May 2002

Patient information sheet

Condition

Intervention

Intervention type

Drug

Phase

Not Applicable

Drug names

Remune™, ALVAC

Primary outcome measures

Time to virologic rebound.

Secondary outcome measures

1. To determine if, in patients with prolonged suppression of viral replication, therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a delay in viral rebound to detectable levels (greater than 50 copies/ml) compared to a scheduled interruption of antiretroviral therapy without prior vaccination (vaccine placebo)2. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in a delay in the rebound of plasma HIV Ribonucleic Acid (RNA) level to 10,000 copies/ml following discontinuation of antiretroviral therapy compared to a scheduled interruption of antiretroviral therapy without prior vaccination3. To determine if therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a delay in the rebound of plasma HIV RNA level to 10,000 copies/ml following discontinuation of antiretroviral therapy compared to a scheduled interruption of antiretroviral therapy without prior vaccination4. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in a decrease in the viral set-point (steady state plasma HIV RNA level) compared to scheduled interruption of antiretroviral therapy without prior vaccination5. To determine if therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a decrease in the viral set-point (steady state plasma HIV RNA level) compared to scheduled interruption of antiretroviral therapy without prior vaccination6. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in a decrease in the magnitude of viral load rebound compared to scheduled interruption of antiretroviral therapy without prior vaccination7. To determine if therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in a decrease in the magnitude of viral load rebound compared to scheduled interruption of antiretroviral therapy without prior vaccination8. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in improved HIV-specific immune function (at week 48) compared to vaccination prior to interruption of therapy (week 24)9. To determine if therapeutic HIV vaccination with Remune™ and ALVAC followed by a scheduled interruption of antiretroviral therapy results in improved HIV-specific immune function compared to scheduled interruption of therapy without prior vaccination (week 48)10. To determine if therapeutic HIV vaccination with ALVAC alone followed by a scheduled interruption of antiretroviral therapy results in improved HIV-specific immune function compared to scheduled interruption of therapy without prior vaccination (week 48)11. To determine if therapeutic HIV vaccination with Remune™ and ALVAC results in improved HIV-specific immune function (in particular, HIV-specific CTL activity) compared to vaccination with ALVAC alone12. To determine if therapeutic HIV vaccination with Remune™ and ALVAC results in improved control of viral replication (time to rebound, time to 10,000 copies/ml, magnitude of rebound, viral set-point) compared to vaccination with ALVAC alone13. To determine which immunologic measures correlate with the rapidity and magnitude of virologic rebound after therapy interruption14. To determine the safety of a complex immune intervention

Overall trial start date

01/04/2001

Overall trial end date

31/03/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. HIV positive CD4 greater than 5002. Age 18 years and older, either sex3. CD4 nadir greater than 2504. Viral load less than 50 for greater than 2 years5. Receiving a Protease Inhibitor (PI) or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)